Name/Company | Approval Dates and Comments |
Collagen-based dermal filler Ortho Dermatologics | The US FDA approved a labeling supplement in June 2009 that includes efficacy and safety data through 12 months, for this collagen-based dermal filler for the correction of moderate to deep facial wrinkles and folds, e.g., nasolabial folds. |
Injectable Poly-L-lactic acid | The US FDA approved this facial injectable in July 2009 for the correction of shallow to deep nasolabial fold (smile lines) countour deficiencies and other facial wrinkles that are treated with the appropriate injection technique in healthy patients. |
Ibritumomab tiuxetan Spectrum Pharmaceuticals | The US FDA approved an expanded label for this product in August 2009 for the treatment of patients with previously untreated follicular non-Hodgkin’s lymphoma who achieve a partial or complete response to first-line chemotherapy. |
Drug News |
In August 2009, the US FDA reported that it is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which included an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases. The FDA is working with the manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs. |
Based on a safety evaluation of botulinum toxin (Btx) products, the US FDA concluded that the prescribing information for OnabotulinumtoxinA (marketed as Botox®/Botox Cosmetic®) and RimabotulinumtoxinB (marketed as Myobloc®) must be updated to ensure their continued safe use. On July 31, 2009, the FDA approved the following revisions to the prescribing information of Botox®/Botox Cosmetic® and Myobloc®:
The other Btx product in this class, abobotulinumtoxinA (marketed as Dysport®), was approved in April 2009 and included the Boxed Warning, REMS, and new established name at the time of approval. The FDA urges healthcare professionals and patients to report side-effects from the use of these products to the FDA’s MedWatch Adverse Event Reporting program. |